Senior Medical Director, Pharmacovigilance


Boston
Permanent
USD320000 - USD360000
Clinical Development
PR/555888_1754428918
Senior Medical Director, Pharmacovigilance

Position Overview

The Senior Medical Director of Drug Safety and Pharmacovigilance plays a pivotal role in shaping the safety strategy across the company's development pipeline. This individual will provide expert guidance on safety matters throughout the product lifecycle-from early development through post-market activities. The role involves leading risk management efforts aligned with global regulatory standards and ensuring continuous evaluation of safety data, signal detection, and benefit-risk assessments. Collaboration across departments is key to meeting project milestones with precision and quality.

Key Responsibilities

  • Develop and execute safety strategies for products within the therapeutic area, ensuring alignment with clinical and commercial objectives.
  • Lead signal detection and management activities, including monitoring, interpreting, and communicating safety data.
  • Chair Product Safety Committee meetings and escalate critical safety concerns to executive leadership as needed.
  • Conduct medical reviews and causality assessments using data from preclinical studies, clinical trials, post-marketing surveillance, and literature.
  • Provide medical input on regulatory documents such as INDs, NDAs, BLAs, protocols, informed consent forms, investigator brochures, and clinical study reports.
  • Oversee the preparation of aggregate safety reports and signal evaluation documentation.
  • Respond to regulatory inquiries related to safety topics with clinical and scientific insight.
  • Guide and support CRO teams to ensure high-quality delivery of outsourced medical safety activities.
  • Collaborate with internal safety scientists and contribute to SOP development to maintain regulatory compliance.
  • Organize and lead internal and external meetings, including data monitoring committees and vendor oversight sessions.
  • Foster strong cross-functional relationships and demonstrate adaptability in a dynamic environment.
  • Promote continuous improvement and training initiatives within the safety function.

Qualifications

  • Medical degree (MD, MBBS or equivalent).
  • Minimum of 7 years of experience in pharmaceutical drug safety and pharmacovigilance.
  • In-depth knowledge of US and EU safety regulations.
  • Experience supporting safety activities in pivotal clinical trials.
  • Strong medical judgment with the ability to align clinical insights with business needs.
  • Proven analytical and scientific reasoning skills.
  • Comprehensive understanding of drug development from discovery through post-market surveillance.
  • Prior experience with regulatory submissions (IND, NDA, BLA) and interactions is highly preferred.
  • Demonstrated success in leading teams within a matrixed environment.
  • Excellent organizational, leadership, and communication skills, with the ability to translate complex data into actionable strategies.

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